NIH Issues Policy to Support Originality and Fairness in Research Application Process

The use of Artificial Intelligence (AI) tools can be helpful in limited aspects of preparing NIH research applications.  However, it is critical to maintain the fairness and originality of NIH’s research application process. The rapid submission of large numbers of research applications from a single Principal Investigator (PI) may also unfairly strain NIH’s application review processes. 

With this in mind, NIH is issuing a policy to outline guidance for appropriate usage of AI in research applications. To support this goal, NIH is also limiting the number of applications that NIH will consider per PI per calendar year.  

Full policy information can be found at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-132.html. Questions may be sent to [email protected].  

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NIH Public Access Policy Mandating Zero Embargo Now in Effect

Effective today, the NIH Public Access Policy is in effect and manuscripts accepted for publication in a journal on or after July 1, 2025, must be submitted to PubMed Central for public availability without embargo upon the official date of publication.

To assist with compliance, NIH has developed a new website dedicated to the Public Access Policy which includes an overview of the policy, supplemental guidance, tips for submitting to PubMed Central, contact information, and FAQs.  The site can be found at: https://grants.nih.gov/policy-and-compliance/policy-topics/public-access.

Questions can be sent to [email protected].

NIH and FDA Publish Glossary of Clinical Research Terms Related to Innovative Clinical Trial Design

The National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) have published a new glossary of clinical research terms related to innovative clinical trial design, including studies using real-world data to generate real-world evidence. This glossary is intended to facilitate communication within the clinical research community by establishing a common vocabulary.

The glossary can be viewed here. In addition, leaders from both NIH and FDA have authored an article published in JAMA Network Open that describes the joint agency effort.

Questions can be sent to [email protected]

NIH Implementation of Executive Order on Improving the Safety and Security of Biological Research

Pursuant to the May 5, 2025, Executive Order on Improving the Safety and Security of Biological Research, NIH is requiring all NIH awardees to review their research portfolios to identify NIH funding and other support for projects meeting the definition of dangerous gain-of-function research. Review must be complete by June 30, 2025. NIH will also be suspending or terminating awards as directed by Executive Order. For more information please see: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-127.html

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